Chronic Ankle InstabilityNCT02794194
Effects of Whole Body Vibration Training on Unstable Surface
A study testing Proprioceptive training on a whole body vibration platform and Proprioceptive training with the BOSU® on the floor in people with Chronic Ankle Instability, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint "giving away" or decreased function. Recently, Whole Body Vibration (WBV) training has been introduced as a preventive and rehabilitative tool. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Proprioceptive training on a whole body vibration platform and Proprioceptive training with the BOSU® on the floor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of at least 1 significant ankle sprain (the most recent injury must have occurred more than 3 months prior to study enrolment).
- 2 or more episodes of the ankle giving way in the last 6 months.
- A score of ≤24 on the Spanish version of the Cumberland Ankle Instability Tool.
- Age range: 18-30 years.
Who cannot join
- History of previous surgeries to the musculoskeletal structures in either lower extremity.
- History of a fracture in either lower extremity requiring realignment.
- An acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function, resulting in at least 1 interrupted day of desired physical activity.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Performance and Sport Rehabilitation Laboratory
Toledo, Toledo, 45071
About this study
Official title: Effects of a Whole Body Vibration Training on Unstable Surface in Recreational Athletes With Chronic Ankle Instability
After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint "giving away" or decreased function. Recently, Whole Body Vibration (WBV) training has been introduced as a preventive and rehabilitative tool. It can be hypothesized that WBV on unstable surfaces might enhance neuromuscular control. Therefore, the aim of this study was to investigate the effects of a 6-week WBV training on an unstable surface on body composition, balance, strength and reflex and muscle activity of ankle muscles in recreational athletes with CAI.
Read the detailed description
Participants:
Fifty physically active recreational athletes with self-reported CAI volunteered to participate in the study. These subjects were assigned to one of three groups: the Vibration group (VIB), Non-Vibration group (N-VIB) and Control group (CON).
Each participant was informed of the risks and discomforts associated with this investigation and signed an informed consent document before the onset of the experiments. The experimental protocol was approved by the Ethics Committee of Clinical Research at the Hospital Complex in Toledo (Spain).
Procedures:
The investigators performed a randomized clinical trial with a cross over design. Participants were assessed at three time points: pre-training (Pre), post-training 1 (Post1) and post-training 2 (Post2) (6 weeks after the last training session). Measurements consisted in a body composition analysis, two balance tests, a forced ankle inversion test and an isokinetic strength test. Assessors and the researcher who performed the statistical analysis were blinded to group allocation. Measurements and the training protocol were developed in the Performance and Sport Rehabilitation Laboratory at the University of Castilla-La Mancha (Toledo, Spain).
Training protocol:
Participants followed a balance training protocol of six weeks for an unstable ankle. Exercises sessions were performed three days a week (48 hours between sessions) on a BOSU® Balance Trainer. All the exercises were carried out only on the unstable ankle and were the same for both experimental groups. Participants in the N-VIB group trained with the BOSU® on the floor, whereas participants in the VIB group trained with the BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium). The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. Following the recommendations of a previous research study18, the level of difficulty was increased in all exercises after three weeks. Also, frequency was progressively increased every two weeks.
Biodex Balance System test:
Ankle balance was assessed with the Biodex Stability System (Biodex Medical Systems, Shirley, New York, USA). The balance test consist of a mobile platform, which allows up to 20° of surface tilt in a 360° range of motion. The platform, which interfaced with computer software (Biodex, Version 1.32, Biodex Medical System), generates three stability indexes: Overall, which represents the platform displacement in all directions; Anterior/Posterior and Medial/Lateral.
The test was performed at level 8 with participants barefoot at single-leg stance. Participants were asked to step on the platform with eyes open and assume a comfortable position while maintaining slight flexion in the knees (15°), to look straight ahead at the monitor and to place their hands in their hips. Foot position coordinates were registered to ensure the same position was used in all tests.
Star Excursion Balance Test (SEBT):
The SEBT, was performed with the participants standing barefoot in the middle of a grid formed by eight tape measures extending out at 45° from each other, each of which was labelled according to the direction of excursion in relation to the standing leg. Participants were asked to maintain a single-stance while reaching with the contralateral leg to touch lightly as far as possible along the chosen direction with the most distal part of their foot and then return to bilateral stance. A standardised protocol of 4 practice trials followed by 3 test trials was performed in each of the eight directions to minimize the learning effect. Reach distances were measured by the same researcher making a mark on the tape measure. The average of the three test trials normalised to leg length of the stance leg was used for analysis.
Body composition:
Height was measured using a wall-mounted stadiometer (model 220, Seca, Hamburg, Germany). Body weight (in underwear) was measured with a digital balance (model 707, Seca, Hamburg, Germany; weighing accuracy of 0.1 kg). Total and regional body composition was measured by dual energy X-ray absorptiometry (Lunar iDXA; GE-Healthcare, Fairfield, CT, USA) using a standardized protocol specified by the manufacturer. Lean mass, fat mass, %fat, bone mineral content and bone mineral density for the total body and for the leg with ankle instability were obtained using the enCORE software (GE Healthcare, v. 13.40).
Inversion test:
Electromyographic (EMG) measurements were taken from the peroneus longus (PL), peroneus brevis (PB) and tibialis anterior (TA). The test was performed on a custom-designed ankle inversion platform capable of producing a 30⁰ inversion, previously used in other research. The start and the end of the inversion was marked by a double axis goniometer (SG110/A, Biometrics Ltd, Gwent, UK) attached to the platform doors to detect any change in the angle of the doors.
Muscular activity was recorded using a portable eight channel telemetry and data logger (ME6000-T8, Mega Electronics, Kuopio, Finland) and was analysed using MegaWin 3.1-b10 software (Mega Electronics, Kuopio, Finland).
Isokinetic test:
Ankle evertor muscles were tested on a Biodex Multi-Joint System 3 dynamometer (Biodex Medical System, New York, USA) at three different velocities: 60, 180 and 300 degrees per second for eccentric and concentric contractions. The isokinetic test was carried out on two different days. The first day, participants were familiarized with the testing procedure and the position on the dynamometer for each participant was registered to ensure that the test was carried out always under the same conditions. Measurements were taken on the second day.
Data analysis:
Statistical analysis was performed using IBM SPSS Statistics v.22.0 (SPSS Inc., Chicago, Illinois, USA). The level of significance was set at p < 0.05. The normality of each variable was initially tested with the Shapiro-Wilk test. All the variables presented a normal distribution. A 2-way repeated measures analysis of variance (ANOVA) was performed for all outcome variables to analyze the interaction between groups (VIB, N-VIB, CON) and the time of assessment (pre-training, post-training 1, post-training 2). The Bonferroni multiple comparison test was performed to account for multiple comparisons. The effect size was calculated in all pairwise comparisons. The magnitude of the effect size was interpreted using Cohen's scale. All the data were presented as mean and standard deviation.
- Conditions
- Chronic Ankle Instability
- Being tested
- Proprioceptive training on a whole body vibration platform, Proprioceptive training with the BOSU® on the floor
- Keywords
- Chronic Ankle Instability, Whole Body Vibration, Proprioception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive training on a whole body vibration platformOther
The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium).
Proprioceptive training with the BOSU® on the floorOther
The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on the floor.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention |
| Vibration group | Experimental | Proprioceptive training on a whole body vibration platform. Participants in the Vibration group trained with a BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium). Receives: Other: Proprioceptive training on a whole body vibration platform |
| Non-vibration group | Experimental | Proprioceptive training with the BOSU® on the floor. Participants in the Non-Vibration group trained with a BOSU® on the floor. Receives: Other: Proprioceptive training with the BOSU® on the floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in electromyographic activity
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Measured: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Change in muscle strength
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Measured: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Change in balance (Biodex Balance System test)
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Measured: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Change in balance (Star Excursion Balance Test (SEBT)
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Measured: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Secondary outcomes (2)
Change in lean mass and fat mass (obtained using the enCORE software (GE Healthcare, v. 13.40)
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Measured: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Change in bone mineral content and bone mineral density (obtained using the enCORE software (GE Healthcare, v. 13.40)
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Measured: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794194
- Sponsor's protocol ID
- LRRD2016/001
- Status last verified
- Jun 2016
- First submitted
- 27 May 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
Publications
Sierra-Guzman R, Jimenez JF, Ramirez C, Esteban P, Abian-Vicen J. Effects of Synchronous Whole Body Vibration Training on a Soft, Unstable Surface in Athletes with Chronic Ankle Instability. Int J Sports Med. 2017 Jun;38(6):447-455. doi: 10.1055/s-0043-102571. Epub 2017 May 9.
PubMed 28486729
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Whole Body Vibration Training on Unstable Surface in Recreational Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT02794194
- Acronym / sponsor ID
- LRRD2016/001
- Conditions
- Chronic Ankle Instability
- Keywords
- Chronic Ankle Instability, Whole Body Vibration, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint "giving away" or decreased function. Recently, Whole Body Vibration (WBV) training has been introduced as a preventive and rehabilitative tool. It can be hypothesized that WBV on unstable surfaces might enhance neuromuscular control. Therefore, the aim of this study was to investigate the effects of a 6-week WBV training on an unstable surface on body composition, balance, strength and reflex and muscle activity of ankle muscles in recreational athletes with CAI.
Detailed description
Participants:
Fifty physically active recreational athletes with self-reported CAI volunteered to participate in the study. These subjects were assigned to one of three groups: the Vibration group (VIB), Non-Vibration group (N-VIB) and Control group (CON).
Each participant was informed of the risks and discomforts associated with this investigation and signed an informed consent document before the onset of the experiments. The experimental protocol was approved by the Ethics Committee of Clinical Research at the Hospital Complex in Toledo (Spain).
Procedures:
The investigators performed a randomized clinical trial with a cross over design. Participants were assessed at three time points: pre-training (Pre), post-training 1 (Post1) and post-training 2 (Post2) (6 weeks after the last training session). Measurements consisted in a body composition analysis, two balance tests, a forced ankle inversion test and an isokinetic strength test. Assessors and the researcher who performed the statistical analysis were blinded to group allocation. Measurements and the training protocol were developed in the Performance and Sport Rehabilitation Laboratory at the University of Castilla-La Mancha (Toledo, Spain).
Training protocol:
Participants followed a balance training protocol of six weeks for an unstable ankle. Exercises sessions were performed three days a week (48 hours between sessions) on a BOSU® Balance Trainer. All the exercises were carried out only on the unstable ankle and were the same for both experimental groups. Participants in the N-VIB group trained with the BOSU® on the floor, whereas participants in the VIB group trained with the BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium). The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. Following the recommendations of a previous research study18, the level of difficulty was increased in all exercises after three weeks. Also, frequency was progressively increased every two weeks.
Biodex Balance System test:
Ankle balance was assessed with the Biodex Stability System (Biodex Medical Systems, Shirley, New York, USA). The balance test consist of a mobile platform, which allows up to 20° of surface tilt in a 360° range of motion. The platform, which interfaced with computer software (Biodex, Version 1.32, Biodex Medical System), generates three stability indexes: Overall, which represents the platform displacement in all directions; Anterior/Posterior and Medial/Lateral.
The test was performed at level 8 with participants barefoot at single-leg stance. Participants were asked to step on the platform with eyes open and assume a comfortable position while maintaining slight flexion in the knees (15°), to look straight ahead at the monitor and to place their hands in their hips. Foot position coordinates were registered to ensure the same position was used in all tests.
Star Excursion Balance Test (SEBT):
The SEBT, was performed with the participants standing barefoot in the middle of a grid formed by eight tape measures extending out at 45° from each other, each of which was labelled according to the direction of excursion in relation to the standing leg. Participants were asked to maintain a single-stance while reaching with the contralateral leg to touch lightly as far as possible along the chosen direction with the most distal part of their foot and then return to bilateral stance. A standardised protocol of 4 practice trials followed by 3 test trials was performed in each of the eight directions to minimize the learning effect. Reach distances were measured by the same researcher making a mark on the tape measure. The average of the three test trials normalised to leg length of the stance leg was used for analysis.
Body composition:
Height was measured using a wall-mounted stadiometer (model 220, Seca, Hamburg, Germany). Body weight (in underwear) was measured with a digital balance (model 707, Seca, Hamburg, Germany; weighing accuracy of 0.1 kg). Total and regional body composition was measured by dual energy X-ray absorptiometry (Lunar iDXA; GE-Healthcare, Fairfield, CT, USA) using a standardized protocol specified by the manufacturer. Lean mass, fat mass, %fat, bone mineral content and bone mineral density for the total body and for the leg with ankle instability were obtained using the enCORE software (GE Healthcare, v. 13.40).
Inversion test:
Electromyographic (EMG) measurements were taken from the peroneus longus (PL), peroneus brevis (PB) and tibialis anterior (TA). The test was performed on a custom-designed ankle inversion platform capable of producing a 30⁰ inversion, previously used in other research. The start and the end of the inversion was marked by a double axis goniometer (SG110/A, Biometrics Ltd, Gwent, UK) attached to the platform doors to detect any change in the angle of the doors.
Muscular activity was recorded using a portable eight channel telemetry and data logger (ME6000-T8, Mega Electronics, Kuopio, Finland) and was analysed using MegaWin 3.1-b10 software (Mega Electronics, Kuopio, Finland).
Isokinetic test:
Ankle evertor muscles were tested on a Biodex Multi-Joint System 3 dynamometer (Biodex Medical System, New York, USA) at three different velocities: 60, 180 and 300 degrees per second for eccentric and concentric contractions. The isokinetic test was carried out on two different days. The first day, participants were familiarized with the testing procedure and the position on the dynamometer for each participant was registered to ensure that the test was carried out always under the same conditions. Measurements were taken on the second day.
Data analysis:
Statistical analysis was performed using IBM SPSS Statistics v.22.0 (SPSS Inc., Chicago, Illinois, USA). The level of significance was set at p < 0.05. The normality of each variable was initially tested with the Shapiro-Wilk test. All the variables presented a normal distribution. A 2-way repeated measures analysis of variance (ANOVA) was performed for all outcome variables to analyze the interaction between groups (VIB, N-VIB, CON) and the time of assessment (pre-training, post-training 1, post-training 2). The Bonferroni multiple comparison test was performed to account for multiple comparisons. The effect size was calculated in all pairwise comparisons. The magnitude of the effect size was interpreted using Cohen's scale. All the data were presented as mean and standard deviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention |
| Vibration group | Experimental | Other: Proprioceptive training on a whole body vibration platformProprioceptive training on a whole body vibration platform. Participants in the Vibration group trained with a BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium). |
| Non-vibration group | Experimental | Other: Proprioceptive training with the BOSU® on the floorProprioceptive training with the BOSU® on the floor. Participants in the Non-Vibration group trained with a BOSU® on the floor. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of at least 1 significant ankle sprain (the most recent injury must have occurred more than 3 months prior to study enrolment).
- 2 or more episodes of the ankle giving way in the last 6 months.
- A score of ≤24 on the Spanish version of the Cumberland Ankle Instability Tool.
- Age range: 18-30 years.
Key exclusion criteria (3 listed)
- History of previous surgeries to the musculoskeletal structures in either lower extremity.
- History of a fracture in either lower extremity requiring realignment.
- An acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function, resulting in at least 1 interrupted day of desired physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive training on a whole body vibration platformThe Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium). | Other | Vibration group |
| Proprioceptive training with the BOSU® on the floorThe Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on the floor. | Other | Non-vibration group |
Primary outcome
Change in electromyographic activity
Time frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Change in muscle strength
Time frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Change in balance (Biodex Balance System test)
Time frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
Change in balance (Star Excursion Balance Test (SEBT)
Time frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)
2 secondary outcomes
Change in lean mass and fat mass (obtained using the enCORE software (GE Healthcare, v. 13.40)
Time frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Change in bone mineral content and bone mineral density (obtained using the enCORE software (GE Healthcare, v. 13.40)
Time frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 28486729Sierra-Guzman R, Jimenez JF, Ramirez C, Esteban P, Abian-Vicen J. Effects of Synchronous Whole Body Vibration Training on a Soft, Unstable Surface in Athletes with Chronic Ankle Instability. Int J Sports Med. 2017 Jun;38(6):447-455. doi: 10.1055/s-0043-102571. Epub 2017 May 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive training on a whole body vibration platform and Proprioceptive training with the BOSU® on the floor in people with Chronic Ankle Instability, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in electromyographic activity (time frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.